- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03855553
Project CORE: Disseminating Eating Disorders Treatment
Disseminating Eating Disorders Education and Treatment Across Multiple Levels of Care: Improving Access in the Rhode Island Medicaid Population
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The complete project will incorporate three phases. Phase I is designed to gather information from existing licensed health professionals in the community who serve Medicaid populations on their knowledge needs and priorities related to screening and intervening with patients with eating disorders. Phase I will comprise eating disorder psycho-education, implementation of workshops, and supervision among primary care professionals and mental health workers. Responses will inform the content of in-services and program development (e.g., monthly consultation services, ongoing multi-family support groups) provided in Phase II.
During Phase II, families containing a child with a restrictive-type eating disorder will be recruited to receive treatment from the clinicians assessed and trained during Phase I. Families will be assigned to receive either Family Based Treatment (FBT) or Enhanced Cognitive Behavioral Therapy (CBT-E) to treat their adolescent's eating disorder. Treatment will occur over 10-16 weeks, depending on the family's needs and availability. Families will be assessed at pre-treatment, post-treatment, and 1-year follow-up.
Phase III will consist of follow-up with the families and clinicians, and further development of training/education approaches for the Rhode Island healthcare workforce.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Recruiting
- The Weight Control & Diabetes Research Center
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Contact:
- Eva-Molly Dunbar
- Email: epetittodunbar@my.uri.edu
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Contact:
- Erin R. Stalvey
- Phone Number: 401-793-8962
- Email: estalvey@lifespan.org
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Principal Investigator:
- Andrea B. Goldschmidt, Ph.D.
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Principal Investigator:
- Christina Tortolani, Ph.D.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria include:
- meets criteria for AN, atypical AN, or BN according to DSM-5 diagnostic criteria
- is currently living at home
- is medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine (e.g., ≥75% of expected body weight, heartrate ≥50 beats per minute)
- if on a psychotropic medication, meets all eligibility criteria while on stable dose of psychotropic medication (8 weeks) for a co-morbid condition
- speaks English
- be available for long-term follow-up.
Exclusion criteria include:
- associated physical illness that necessitates hospitalization
- psychotic illness/other mental illness requiring hospitalization
- current dependence on drugs or alcohol
- physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
- concurrent involvement in other psychological treatment for an eating disorder
- developmental delay that would preclude participation in the intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: FBT
10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.
|
10 families will be randomized to receive 10 - 16 weeks of Family Based Treatment (FBT), the "gold standard" in eating disorder treatment for adolescents.
FBT is a highly structured behavioral intervention in which caregivers are charged with the primary task of re-feeding their child and normalizing his or her eating behaviors and weight status.
Other Names:
|
EXPERIMENTAL: CBT-E
10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.
|
10 families will be randomized to receive 10 - 16 weeks of Enhanced Cognitive Behavioral Therapy (CBT-E), a clinically validated treatment for adolescent eating disorders.
CBT-E is a short-term, individual treatment focused on normalizing eating behaviors and modifying underlying cognitions that contribute to the maintenance of eating disorder behaviors (e.g., over-importance of shape and weight in one's self-evaluation).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI percentile
Time Frame: post treatment (week 17)
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post treatment (week 17)
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BMI percentile
Time Frame: 1 year follow up
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1 year follow up
|
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Eating disorder symptomology, as assessed by the EDE-Q.
Time Frame: post treatment (week 17)
|
Patient will complete the Eating Disorder Examination Questionnaire (EDE-Q) to assess the frequency and severity of specific eating disorder behaviors and cognitions.
Averages of the 28-item measure range from 0 to 6, with higher score indicating higher eating disorder symptomology.
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post treatment (week 17)
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Eating disorder symptomology, as assessed by the ED-15.
Time Frame: post treatment (week 17)
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Patient will complete the Eating Disorder 15 (ED-15) to assess the frequency and severity of specific eating disorder behaviors and cognitions.
Average scores from the 15-item measure range from 1 - 5, with higher scores indicating higher eating disorder symptomology.
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post treatment (week 17)
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Eating disorder symptomology, as assessed by EDE-Q
Time Frame: 1 year follow-up
|
Patient will complete the Eating Disorder Examination Questionnaire (EDE-Q) to assess the frequency and severity of specific eating disorder behaviors and cognitions.
Average scores of the 28-item measure range from 0 to 6, with higher score indicating higher eating disorder symptomology.
|
1 year follow-up
|
Eating disorder symptomology, as assessed by ED-15.
Time Frame: 1 year follow-up
|
Patient will complete the Eating Disorder 15 (ED-15) to assess the frequency and severity of specific eating disorder behaviors and cognitions.
Average scores from the 15-item measure range from 1 - 5, with higher scores indicating higher eating disorder symptomology.
|
1 year follow-up
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Perceived efficacy of treatment, as assessed by the TSPE
Time Frame: post treatment (week 17)
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One item from the Treatment Suitability and Patient Expectancy (TSPE) survey will assess how successful the patient perceived treatment to be.
This item ranges from 0 - 10, with higher scores indicating higher perceived efficacy.
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post treatment (week 17)
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Perceived efficacy of treatment, as assessed by the CSQ
Time Frame: post treatment (week 17)
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The Client Satisfaction Questionnaire (CSQ) is an 8-item measure that assesses how successful the patient perceived treatment to be.
Average scores range from 1 - 4, with higher scores indicating higher satisfaction and perceived efficacy.
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post treatment (week 17)
|
Perceived efficacy of treatment, as assessed by the CSQ
Time Frame: 1 year follow-up
|
The Client Satisfaction Questionnaire (CSQ) is an 8-item measure that assesses how successful the patient perceived treatment to be.
Average scores range from 1 - 4, with higher scores indicating higher satisfaction and perceived efficacy.
|
1 year follow-up
|
Perceived efficacy of treatment, as assessed by the TSPE.
Time Frame: 1 year follow-up
|
One item from the Treatment Suitability and Patient Expectancy (TSPE) survey will assess how successful the patient perceived treatment to be.
This item ranges from 0 - 10, with higher scores indicating higher perceived efficacy.
|
1 year follow-up
|
Perceived feasibility of treatment, as assessed by the TSPE.
Time Frame: post treatment (week 17)
|
One item from the Treatment Suitability and Patient Expectancy (TSPE) survey will assess how feasible the patient perceived treatment to be.
This item ranges from 0 - 10, with higher scores indicating higher feasibility.
|
post treatment (week 17)
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Perceived feasibility of treatment, as assessed by the CSQ.
Time Frame: post treatment (week 17)
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Two items from the 8-item Client Satisfaction Questionnaire (CSQ) will assess how suitable/feasible treatment was based on the patient's needs, family dynamics, schedule constraints, etc.
Average scores range from 1 - 4, with higher scores indicating higher feasibility.
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post treatment (week 17)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrea B. Goldschmidt, Ph.D., Weight Control & Diabetes Research Center
- Principal Investigator: Christina Tortolani, Ph.D., Rhode Island College
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1319865
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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